PCORI Biweekly COVID-19 Scan: Incentive Programs for Vaccine Uptake, Investigational Outpatient Treatment (June 10-23, 2021)
The Briefing provides an at-a-glance view of some important developments in the information universe surrounding COVID-19. The views presented here are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders.
Oral antiviral drugs, such as molnupiravir (see Topics to Watch), are in development, but none are yet available. Incentive programs are aiming to increase vaccination uptake (see Topics to Watch), but the United States is not on track to meet the July 4 aspiration of 70% of adults having received at least one vaccine dose. In addition, the rise of the Delta variant in the United States could lead to surges in COVID-19 cases among the unvaccinated.
Two new National Institutes of Health (NIH) research initiatives aim to combat these situations and to speed the progress of biomedical innovations in general. The first, the Antiviral Program for Pandemics, will invest $3 billion from the American Rescue Plan to fund discovery, development, and manufacturing of oral antivirals, including molnupiravir. The second, the Advanced Research Projects Agency for Health, aims to expand the lessons learned from the success of accelerated vaccine development to yield breakthroughs in other diseases, such as Alzheimer’s disease and cancer.
ECRI Horizon Scanning has selected the topics below as those with potential for impact relative to COVID-19 in the United States within the next 12 months. All views presented are preliminary and based on readily available information at the time of writing.
Because these topics are rapidly developing, we cannot guarantee the accuracy of this information after the date listed on this publication. In addition, all views expressed in the commentary section are solely those of ECRI Horizon Scanning and have not been vetted by other stakeholders. Topics are listed in alphabetical order.
Incentive Programs to Increase COVID-19 Vaccine Uptake
At a Glance
- Vaccine incentive programs are intended to increase community uptake of COVID-19 vaccines and to reduce infection spread, hospitalizations, mortality rates, and health care costs related to COVID-19.
- These programs vary but generally help the public gain access to vaccination sites or receive a reward (eg, lottery entry, gift cards) after getting vaccinated.
- Some companies offer additional incentives, such as providing paid time off for employees who are not yet vaccinated to get their shots.
- Results from the statewide vaccination lotteries and other financial incentives show an encouraging increase in vaccination rates in California and Ohio. The impact of the lottery program on Maryland vaccination rates is still under investigation.
Although the currently available COVID-19 vaccines have shown high efficacy against disease, a segment of the public remains hesitant to be vaccinated because of concerns regarding the development of the vaccines and the quick authorization process of the US Food and Drug Administration (FDA). To reduce this vaccine hesitancy and increase vaccination rates, many incentive programs have been launched.
Some universities and health systems have also mandated vaccines for returning students and employees. On May 28, 2021, the guidelines provided by the US Equal Employment Opportunity Commission stated that companies may mandate COVID-19 vaccines (with an exemption for medical or religious beliefs) for employees returning to work. However, a survey conducted in May 2021 found that 72% of employers responded that they will not require their employees to be vaccinated before entering the workplace. Instead, many employers are offering incentives to increase vaccine uptake in employees. These incentives are either in the form of flexibility (eg, free child care, free transportation to vaccination sites) or monetary rewards (eg, paid time off for the shot, bonuses).
Additionally, broader public incentives have been offered in some states (eg, California, Maryland, Ohio), which have launched vaccination lotteries. Results reported a week after the Ohio Vaccine Lottery showed an increase of vaccinations by 55% for residents aged 20 to 49 years and 94% for residents aged 16 to 17. Similar increases were noted after the launch of the California lottery and incentives program. The impact of the lottery program on Maryland vaccination rates is still under investigation.
Vaccine incentives might improve population health outcomes and reduce disparities in lower socioeconomic status groups concerned about the safety of the vaccines or missing work to get the vaccine. These programs might increase people’s willingness to get a COVID-19 vaccine by reducing barriers to access and providing financial incentives for being inoculated. It might also reduce the death rates and health care costs related to COVID-19.
Early feedback from ECRI internal stakeholders suggested that government and employer incentives might promote vaccinations in the employed and unemployed populations; however, these incentives might feel coercive to some individuals who did not intend to get vaccinated and may stagnate the vaccination rates. Providing incentives might produce a short-term bump in vaccinations; however, providing financial incentives alone might not lead to a sustained uptake in all hesitant individuals. Additional strategies might be required to identify and address sources of vaccine hesitancy (eg, safety concerns for pregnant women) and health education to build public trust, especially in underserved communities.
- Categories: Systems and management
- Areas of potential impact: Patient outcomes, population health, health care disparities, health care costs
Molnupiravir to Treat Outpatient Mild to Moderate COVID-19
At a Glance
- Molnupiravir is an investigational oral nucleoside analogue prodrug that is being developed to treat mild to moderate COVID-19 in the outpatient setting.
- Molnupiravir purportedly is converted in the body to a cytidine analogue that incorporates into viral RNA during replication and increases the error rate such that it renders the virus nonfunctional.
- Its developers are conducting a phase 2/3, randomized, placebo-controlled trial enrolling 1850 patients with mild to moderate COVID-19 in over 100 locations inside and outside of the United States. The trial’s estimated primary completion date is in October 2021.
- The US government announced plans to purchase 1.7 million courses of molnupiravir to treat COVID-19 if the drug receives emergency use authorization (EUA) or FDA approval.
Current FDA-approved treatments for COVID-19 are limited to the antiviral remdesivir and spike protein-specific monoclonal antibody therapies, all of which require intravenous administration in a health care setting. Molnupiravir (Ridgeback Biotherapeutics, Miami, Florida) is being investigated as a COVID-19 treatment that could be taken by mouth in the outpatient setting, which might not only increase patient ease of access to COVID-19 treatment but also allow for earlier antiviral intervention.
Molnupiravir (EIDD-2801/MK-4482) is a drug that is converted to its active state within the body and becomes the nucleoside analogue N4-hydroxycytidine, which purportedly exerts antiviral effects by incorporating into viral RNA and causing an increase in the mutation rate of the virus when it replicates. Mutations induced by molnupiravir purportedly lead to error catastrophe, in which a large number of mutations renders the virus nonfunctional. By inhibiting SARS-CoV-2 in this manner, molnupiravir might be able to slow and eventually stop the growth of the virus. This could limit disease severity, prevent viral transmission, and improve patient health outcomes.
Molnupiravir is being studied in an ongoing phase 2/3, randomized, placebo-controlled trial of 1850 patients with mild to moderate COVID-19 in the outpatient setting. The trial’s estimated primary completion date is in October 2021. In a phase 2a study, it was found to shorten time to SARS-CoV-2 negativity on nasopharyngeal swabs. The US government announced plans to purchase 1.7 million courses of molnupiravir to treat COVID-19, if the drug receives EUA or FDA approval.
Molnupiravir is an investigational oral therapy for treating mild to moderate COVID-19 in the outpatient setting. If effective, it might help meet the ongoing need for early COVID-19 treatments to help prevent hospitalization, reduce COVID-19 health complications, and reduce the burden on the health care system.
Initial comments from internal ECRI stakeholders suggested that molnupiravir could provide physicians with an outpatient treatment that might help reduce severity and length of illness and decrease hospitalizations from COVID-19. If well tolerated, it might help diminish health disparities by increasing outpatient access to care, compared with treating mild to moderate COVID-19 with intravenous monoclonal antibody therapy.
Molnupiravir’s upfront cost might be offset if it demonstrates efficacy in reducing disease severity and preventing hospitalization. However, stakeholders noted that pending safety and efficacy data from ongoing trials are needed to determine molnupiravir’s potential to disrupt health outcomes and costs, and ultimately, whether it will be used clinically.
- Category: Treatments
- Areas of potential impact: Patient outcomes, population health, health care disparities, health care costs
Horizon scanning is a systematic process that serves as an early warning system to inform decision makers about possible future opportunities and threats. Health care horizon scanning identifies technologies, innovations, and trends with potential to cause future shifts or disruptions—positive or negative—in areas such as access to care, care delivery processes, care setting, costs of care, current treatment models or paradigms, health disparities, health care infrastructure, public health, and patient health outcomes.
The PCORI Health Care Horizon Scanning System (HCHSS) conducts horizon scanning to better inform its patient-centered outcomes research investments. Initially, PCORI defined the HCHSS project scope to focus on interventions with high potential for disruption in the United States in 5 priority areas: Alzheimer’s disease and other dementias, cancer, cardiovascular diseases, mental and behavioral health conditions, and rare diseases. In addition, the system captures high-level disruptive trends across all clinical areas, which may lead PCORI to expand the project scope to include other priority areas in the future.
In early 2020, the COVID-19 pandemic created a fast-moving, widespread public health crisis. In May 2020, PCORI expanded its HCHSS to elucidate the landscape of potentially impactful applications for COVID-19. The HCHSS COVID-19 supplement scans for, identifies, monitors, and reports on emerging and available COVID-19-related treatments, diagnostics, preventive measures, management strategies, and systems changes with potential for high impact to patient outcomes—for individuals and populations—in the United States in the next 12 months.
The HCHSS COVID-19 supplement produces 3 main outputs:
- Biweekly COVID-19 Scans (eg, this document) provide ECRI Horizon Scanning with a vehicle to inform PCORI and the public in a timely manner of important topics of interest identified during ongoing scanning and topic identification or through the ECRI stakeholder survey process.
- Status Reports (quarterly) briefly list and describe all COVID-19-related topics identified, monitored, and recently archived.
- High Impact Reports (every 4 months) highlight those topics that ECRI internal stakeholders (eg, physicians, nurses, allied health professionals, public health professionals, first responders, health systems experts, clinical engineers, researchers, business and finance professionals, and information technology professionals) have identified as having potential for high impact relative to COVID-19 in the United States.
Commentary in this COVID-19 Scan reflects preliminary views of ECRI Horizon Scanning and internal ECRI stakeholders.
The information contained in this document has not been vetted by other stakeholders.
We welcome your comments on this Scan. Send them by email to [email protected].
Posted: July 7, 2021
What's Happening at PCORI?
The Patient-Centered Outcomes Research Institute sends weekly emails about opportunities to apply for funding, newly funded research studies and engagement projects, results of our funded research, webinars, and other new information posted on our site.